Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatment belatacept
Phase phase 1/phase 2
Target CTLA-4
Sponsor University of California, San Francisco
Collaborator Juvenile Diabetes Research Foundation
Start date February 2004
End date January 2017
Trial size 30 participants
Trial identifier NCT00501709, 39-42C

Summary

Pancreatic islets are the part of the pancreas that produce insulin and help control the blood sugar. This study aims to improve islet transplantation as a treatment for Type 1 Diabetes by using a new combination of immunosuppressive drugs that have been successful in treating other autoimmune diseases and in preventing kidney transplant rejection.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
lnsulin independence
time frame: monthly

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Type 1 Diabetes - Metabolic lability/instability characterized by hypoglycemia or ketoacidosis(>2 hospital admissions in the previous year), erratic glucose profiles(MAGE >120mg/dL), or disruption in lifestyle(danger to life, self or others). Reduced awareness of hypoglycemia or > 1 episode in the last 1.5 years of severe hypoglycemia. - Persistently poor glucose control (as defined by HgbA1c>10% at the end of six months of intensive management efforts with diabetes care team. - Progressive secondary complications as defined by - a new diagnosis by an ophthalmologist of proliferative retinopathy or clinically significant macular edema or therapy with photocoagulation during the last year; or - urinary albumin excretion rate >300mg/day but proteinuria <3g/day; or - symptomatic autonomic neuropathy (as defined by postural hypotension in the setting of euvolemia, gastroparesis or diarrhea attributed to diabetic neuropathy, or neuropathic bladder as diagnosed by an urologist) Exclusion Criteria: - Patient weighs more than 80kg or body mass index BMI>28 - Patient's insulin requirement is >55 Units/day. - Current use of immunosuppressive agents. - History of malignancy within 10 years (except for adequately treated basal or squamous cell CA of the skin). - Active peptic ulcer disease. - Severe unremitting diarrhea or other GI disorders potentially interfering with the ability to absorb oral medications. - Untreated proliferative retinopathy. - Pregnancy or breastfeeding. - Female subjects not post-menopausal or surgically sterile, or not using an acceptable method or contraception. - Active infections. - Major ongoing psychiatric illness. - Ongoing substance abuse, drug or alcohol; or recent history of noncompliance. - Portal hypertension or history of significant liver disease. - Lymphopenia (<1000/ul) or leukopenia (<3000 total leukocytes/ul) or an absolute CD4 count <500/ul. - Presence or history of panel-reactive anti-HLA antibody >20%. - Evidence of acute EBV infection (IgM>IgG) OR no serologic evidence of previous exposure to EBV (IgG>IgM). - Serologic evidence of infection with HIV or HbsAg or HCV Ab positive. - Creatinine clearance <60ml/min/m2. - Positive lymphocytoxic cross-match using donor lymphocytes and serum

Additional Information

Principal investigator Peter G Stock, M.D., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by University of California, San Francisco.